Manager, Regulatory Affairs – Long Island, NY area
My client is a Medical Device company leading the industry in service, quality products and strategic partnerships. They have been around for over 20 years and have consistently experienced double-digit growth annually. Employees stay for the positive, collaborative work environment and great team members. We are in search for a Manager of Regulatory Affairs.
The ideal candidate will have a collaborative disposition and the following qualifications:
- Bachelor’s degree & 5 to 7 years of Regulatory Affairs experience
- Knowledge of importing / manufacturing / sterilization of Med. Devices
- Expert knowledge in Domestic and International registrations and filings (ISO, CAPA, 510K, FDA, UDI, NCR, CMDR)
- Assist with development of regulatory strategies to support product development and operational objectives
- Provide regulatory feedback and guidance to the company throughout the product development life cycle
- Independently prepare regulatory documents for product submissions or compliance actions
- Collaborate with appropriate departments to ensure applicable materials are developed for new product market clearance, approval and continuance during product life cycle; assemble materials and data required for timely completion of regulatory submissions: 510(k), and technical file for Notified Body. Review and approve label claims and artwork
- Submit all FDA documentation and registrations to assure new products meet regulatory requirements
- Ensure that reporting requirements regarding new, old and modified devices requirements under European MDD, CE and Canadian MDSAP are met
- Plans and implements organizational policies and goals
- Responsible for maintaining all the Regulatory Master files in conjunction with the China Office, including managing vendor Certificates of Compliance system
- Ensures that company is in full compliance with FDA and Health Canada regulations and ISO requirements
- Maintain appropriate domestic and international registrations and product listings.
- Compile all documentation needed for annual reporting and approval supplements.
- Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions
- Assist with the development, update, and adherence to standard operating procedures to meet regulatory standards
- Coordinates activities of the Quality Assurance function and other departments in order to maintain high levels of product quality. Communicate regulatory and quality policy to other departments as necessary to assure compliance
** Occasional international travel to the corporate location is required
If qualified, let’s connect to discuss the details. It’s a terrific opportunity for a someone looking to progress to a manager level at a great company and grow their career.
Keywords: ISO, CAPA, 510K, FDA, UDI, NCR, CMDR, product listing, product registration, medical device, disposable. ETO, gamma, sterilization.